Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth (PPPTP)
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|ClinicalTrials.gov Identifier: NCT02350231|
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 24, 2017
Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.
Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.
Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.
Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.
Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Drug: The progesterone vaginal pessary Drug: Tonics group||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||February 1, 2014|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||January 15, 2017|
Active Comparator: The progesterone vaginal pessary group
Where they will have progesterone vaginal pessary (Prontogest 400 mg) daily at bed time from 28 weeks of pregnancy till delivery in addition to tonic and calcium
Drug: The progesterone vaginal pessary
Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
Other Name: Active drug treatment
Placebo Comparator: Tonics group
Where they will receive only tonics and calcium from 28 weeks of pregnancy till delivery
Drug: Tonics group
Those patients will receive only tonics
Other Name: Placepo
- Time of delivery [ Time Frame: from 28 weeks till delivery ]
- Mode of delivery [ Time Frame: from 28 weeks till delivery ]
- Birth weight [ Time Frame: at time of delivery ]
- The need for neonatal intensive care incubator. [ Time Frame: after delivery ]